SKIN DEFENSE MAKEUP SPF-15- octinoxate octisalate oxybenzone lotion

SKIN DEFENSE MAKEUP by

Drug Labeling and Warnings

SKIN DEFENSE MAKEUP by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3

PURPOSE

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT

OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL ISOSTEARATE, DI-PPG-3 MYRISTYL ETHER ADIPATE, STEARIC ACID, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE,  LECITHIN, POLYETHYLENE, METHYL METHACRYLATE COPOLYMER, SILICA, DIMETHICONE, SODIUM HYALURONATE, TREHALOSE, SODIUM PCA, POLYQUATERNIUM-51, UREA, GLYCERIN, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYSORBATE 20, TRIETHANOLAMINE, TAGETUS ERECTA (AFRICAN MARIGOLD) EXTRACT, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, PROPYLENE GLYCOL, MACROCYSTIS PYRIFERA EXTRACT,  HYDROLYZED WHEAT PROTEIN, PVP, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, FRAGRANCE/PARFUM, PANTHENOL, TOCOPHERYL ACETATE, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA [MAY CONTAIN, +/-: TITANIUM DIOXIDE/CI 77891, IRON OXIDES/CI 77491/CI 77492/CI 77499]  [FRAGRANCE/PARFUM CONTAINS: CITRONELLOL, ALPHA-ISOMETHYL IONONE, GERANIOL, LIMONENE, LINALOOL].

INDICATIONS & USAGE

SPF 15 PROTECTS AGAINST DAMAGING ULTRAVIOLET RAYS. MATTE FINISH. SHEER TO MEDIUM COVERAGE.

INSTRUCTIONS FOR USE

TO USE: SMOOTH ON WITH FINGERS OR SPONGE.

WARNINGS

CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

STOP USE

DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

JAFRA

SKIN DEFENSE MAKEUP SPF 15

INGREDIENTS AND APPEARANCE

SKIN DEFENSE MAKEUP  SPF-15
octinoxate octisalate oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-147
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ZINC OXIDE (UNII: SOI2LOH54Z)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
METHYL METHACRYLATE (UNII: 196OC77688)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)
UREA (UNII: 8W8T17847W)
GLYCERIN (UNII: PDC6A3C0OX)
OAT (UNII: Z6J799EAJK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
TAGETES ERECTA FLOWER (UNII: UH5X33P33E)
IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
POVIDONE K30 (UNII: U725QWY32X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
PANTHENOL (UNII: WV9CM0O67Z)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
EDETATE TRISODIUM (UNII: 420IP921MB)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-147-11	1 in 1 BOX
1	NDC: 68828-147-67	30 mL in 1 BOTTLE
2	NDC: 68828-147-10	10 in 1 BOX
2	NDC: 68828-147-17	8 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/24/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture